Teva to sell contraceptive OTC without age restriction

24 Jun 2013, BioSpectrum Bureau , BioSpectrum

Singapore: The US FDA has in an attempt to comply with an order from a US District Court judge in New York, expanded its approval of a contraceptive pill to include all women who are capable of bearing a child.

Plan B One-Step, which is sold by Teva Pharmaceutical, is a single dose pill intended to reduce the chance of pregnancy following unprotected sex or suspected contraceptive failure, such as a broken condom. The FDA said the emergency contraceptive would be made available as an over-the-counter (OTC) product without age or point-of-sale restrictions.

Mr Janet Woodcock, long-time director, Center for Drug Evaluation and Research, FDA, said in a statement that, "Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the US."

The drug, which is popularly known as the 'morning after' pill was originally approved in 2009 without a prescription for women age 17 and older, and as a prescription-only option for women younger than 17. In April 2013, the pill was approved for non-prescription use for women aged 15. However, the court ordered that age restrictions be removed for all women capable of bearing children.